RecruitingNot ApplicableNCT06505564

VR-based Avatar Therapy for Treatment of Auditory Hallucinations

VR-based Avatar Therapy for Treatment of Auditory Hallucinations in Patients With Schizophrenia 2023-SUD-3446


Sponsor

Semmelweis University

Enrollment

90 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The primary aim of this study is to evaluate the safety and efficacy of AVATAR therapy, developed to address residual auditory hallucinations persisting despite medication in schizophrenia spectrum disorder. The intervention aims to reduce the intensity and frequency of these symptoms, as well as alleviate associated depressive and anxiety symptoms, using a virtual reality (VR)-assisted intervention developed for this purpose by the Danish company HEKA VR. The study will be a pre-post non-invasive, waiting list-controlled study, enrolling 30 patients from three clinical sites (Hungary, Spain, Poland). The study centers around administering therapy based on VR over a 12-week period, comprising a total of 7 sessions. These sessions are conducted individually and last 50 minutes each. The psychotherapist leading the sessions adheres to a strict protocol defined by the method's developers. During the intervention, VR technology is used to simulate the source of distressing auditory hallucinations. The therapist facilitates coping with these experiences externalized in this way through simulated conversations, supporting the development of more adaptive responses. Patients undergo a comprehensive cross-sectional evaluation of their condition before and after the intervention, including assessments of symptom severity, quality of life, and their experience with the method. The intervention is conducted with constant monitoring for possible adverse effects.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests VR-based avatar therapy for people who experience auditory hallucinations (hearing voices) as part of a schizophrenia spectrum disorder. Participants work with a therapist to create a virtual avatar representing the voice they hear, and through guided sessions, learn to confront and gain control over it. The study is run at multiple sites in Hungary, Spain, and Poland. **You may be eligible if...** - You are 18 or older with a diagnosis of a schizophrenia spectrum disorder - You have been hearing voices for at least 3 months - You are on a stable medication dose for at least 4 weeks - You have regular psychiatric follow-up care - You speak Hungarian, Spanish, or Polish fluently **You may NOT be eligible if...** - You cannot identify a single dominant voice for the therapy to focus on - You have an intellectual disability or serious cognitive impairment - You regularly misuse substances - You have active suicidal risk - You have severe visual impairment or aversion to virtual reality Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALAVATAR therapy

In the initial phase of treatment, patients collaborate with therapists to visualize the source of their auditory hallucinations. Therapists adjust their voice to match the hallucinations, prompting patients to recall key statements for future sessions. Subsequent sessions involve dialogues with a computerized avatar. Using the altered voice, therapists interact in real-time through the avatar, engaging patients in role-playing. They alternate between the avatar and supportive therapist roles to empower patients with positive affirmations and discussions. Sessions last approximately 50 minutes, utilizing Oculus Rift VR headsets and noise-cancelling headphones to enhance immersion. HEKA VR software adjusts avatar proximity, and patients have the option to record dialogues for home use and sharing. Therapists receive bi-weekly supervision from HEKA VR-trained colleagues. Participants continue their regular medication prescribed by their psychiatrists alongside this experimental therapy


Locations(4)

Semmelweis University

Budapest, Hungary

Uniwersytet Medyczny w Łodzi

Lodz, Poland

Unitat de Recerca del Parc Sanitari Sant Joan de Déu

Barcelona, Spain

University of Barcelona

Barcelona, Spain

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NCT06505564


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